(157 days)
Enzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma
Not Found
The provided text {0} {1} {2} is an FDA 510(k) clearance letter for a device named "Glycacor" and does not contain the specific information required to answer the prompt.
The document states that the Glycacor device is an "Enzyme linked Immunosorbent Assay (ELISA), non-radioactive, for determination of glycated LDL (low-density lipoprotein) in plasma." It confirms that the FDA reviewed the 510(k) submission and determined the device to be substantially equivalent to legally marketed predicate devices.
However, the letter does not include:
- Acceptance criteria or reported device performance.
- Details on sample sizes, data provenance, or expert qualifications for any study.
- Adjudication methods.
- Information about multi-reader multi-case comparative effectiveness studies or standalone algorithm performance.
- The type of ground truth used or how it was established.
- The sample size for the training set.
Therefore, I cannot provide the requested table and study details based on the given information. The document is strictly an FDA clearance letter and not a performance study report.
§ 864.7470 Glycosylated hemoglobin assay.
(a)
Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a , A1b , and A1c ) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.(b)
Classification. Class II (performance standards).